PeriOperative ISchemic Evaluation-2 Trial (POISE-2)

This study has been completed.

Sponsor:

Hamilton Health Sciences Corporation

ClinicalTrials.gov Identifier:

NCT01082874

First Posted: March 9, 2010

Last Update Posted: August 25, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery

Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery

Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery

Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery

Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery

Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery

Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery

Total

Total of all reporting groups

Baseline Measures

Active Clonidine and Active ASA

Active Clonidine and Placebo ASA

Placebo Clonidine and Active ASA

Placebo Clonidine and Placebo ASA

Total

Overall Participants Analyzed [Units: Participants]

2499

2510

2499

2502

10010

Age [Units: Participants]

<=18 years

0

0

0

0

0

Between 18 and 65 years

873

836

836

866

3411

>=65 years

1626

1674

1663

1636

6599

Age [Units: Years]Mean (Standard Deviation)

68.4 (10.4)

68.6 (10.3)

68.7 (10.2)

68.5 (10.3)

68.6 (10.3)

Gender [Units: Participants]

Female

1212

1164

1188

1160

4724

Male

1287

1346

1310

1340

5283

Region of Enrollment [Units: Participants]

Colombia

162

161

164

162

649

Argentina

3

2

3

3

11

Hong Kong

69

70

69

68

276

United States

443

440

437

440

1760

United Kingdom

22

22

22

20

86

Malaysia

30

28

30

32

120

Switzerland

24

24

25

23

96

India

149

149

151

146

595

Spain

133

139

131

135

538

New Zealand

14

11

11

10

46

Canada

875

878

872

873

3498

Austria

44

44

42

46

176

Pakistan

43

44

44

44

175

Belgium

44

47

46

47

184

Brazil

13

12

16

16

57

Denmark

80

80

80

81

321

Italy

39

39

38

38

154

South Africa

87

87

89

90

353

Australia

119

120

113

118

470

Chile

38

38

38

39

153

France

21

24

24

20

89

Peru

41

44

43

44

172

Germany

6

7

11

7

31

Outcome Measures

1. Primary:

Composite of All-cause Mortality and Nonfatal MI [ Time Frame: 30 days ]